TCD-11226

JRCT ID: jRCT2052230047

Registered date:21/06/2023

Basic Information

• Recruitment status: Suspended
• Health condition(s) or Problem(s) studied: Residual aortic dissection (including pseudoaneurysm at the anastomotic site) after ascending aortic
• Date of first enrollment: 21/06/2023
• Target sample size: 42
• Study type: Interventional
• Intervention(s): Use TCD-11226 for the thoracic aorta, brachial artery, and left common carotid artery. Note that for one case, the placement of TCD-11226 will consist of one TCD-11226 main stent graft and two TCD-11226 branch stent grafts. If it is anticipated that blood flow obstruction to the lesion at the distal end of the aorta is insufficient during the placement of the main device, TCD-RPN can be used.

Outcome(s)

Primary Outcome

1. Primary endpoint
(1) Effectiveness endpoint
Percentage of subjects achieving all of the following four items up to 1 year after treatment:
1 No occurrence of stent-graft migration (>=10 mm)
2 No occurrence of complete occlusion of branch stent-grafts
3 No secondary therapeutic intervention for Type I or Type III endoleaks
4 No occurrence of death due to aortic rupture at the treatment site

(2) Safety endpoint
Percentage of subjects with any of the following six events within 30 days after treatment (6 judged on the day of treatment):
1 All-cause mortality
2 Stroke
3 Paraplegia/Paraparesis
4 New post-treatment dialysis
5 Aortic rupture at the treatment site
6 Unsuccessful device placement

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. Age is >= 18 years at the time of informed consent.
2. Patients considered suitable for TEVAR using thoracic stent-graft system TCD-11226 after comprehensive evaluation of risk factors and consideration of other treatment options.
3. Patients with a minimum inner diameter of the central landing zone of the TCD-11226 main stent-graft of 28 mm or larger.
4. Patients with no dissection in BCT and LCCA, which are landing zones of the TCD-11226 branch stent-graft.
5. Patients with femoral/iliac artery diameter accessible with 25 Fr delivery catheter.

Exclude criteria

1. Patients with inaccessible access from the femoral or iliac artery.
2. Patients with difficult-to-pass stenosis or Grade 2 or higher atherosclerotic thrombosis in the TCD-11226 branch stent-graft device approach vessel.
3. Patients with Grade 2 or higher atherosclerotic thrombosis at the landing zone of the TCD-11226 branch stent-graft.
4. Patients who have had symptomatic stroke or cerebral hemorrhage within 6 months prior to trial registration.
5. Patients who have participated in another clinical trial of a pharmaceutical product or medical device within 1 year prior to trial registration.

Related Information

• Primary Sponsor: Sugisaki Shunichiro